Simultaneous Cardiac Surgery and Micronet-covered Stent Carotid Revascularization in High Perioperative Stroke Risk Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJohn Paul II Hospital, Krakow

About this trial

Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in combination with cardiac surgery (coronary artery bypass grafting (CABG) and/or valve surgery). A study involving clinical data evaluation of truly simultaneous treatment outcomes in patients deemed to require carotid revascularization at the time of surgical cardiac intervention (single-stage, simultaneous treatment). An open-label study, without randomization - a single arm study.

Academic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.

Eligibility criteria

Qualifiers

Patients eligible for concomitant carotid artery stenting in conjunction with cardiac surgery based on Heart Team and NeuroVascular Team reccomendation and according to local standards of practice.

Signed informed consent form

Consent to (routinely performed in this group of patients) follow-up visits and tests performed (routinely) during long-term follow-up

De novo atherosclerotic lesions or neo-atherosclerosis.

Disqualifiers

Expected survival time <1 year (e.g., cancer).

Renal failure with GFR < 20 ml/min/1.73 m2 as calculated by the CKD-EPI formula

Women who are pregnant (pregnancy test).

Coagulopathies.

Trial design

Treatments tested in this trial

  • Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators